Solicitation

Manufacture of Paclitaxel (PTX) encapsulated in two different tumor-penetrating microparticles (TPM-001)

Person of Contact Heather Housaman (heather.housaman@nih.gov)
Proposal Due Date Wednesday, April 10, 2024 (Closed 2 days 15 hours ago)
NAICS Codes 541715, 541714
  • Research Category Research & Development Services & Subcontracts
  • Solicitation Number S24-028
  • NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

Leidos Biomed is seeking to manufacture a second batch of Paclitaxel (PTX) encapsulated in two different tumor-penetrating microparticles (TPM-001). The two TPMs shall exhibit two different release rates, one slow-release, and the other fast-release.

Objectives:

1. Manufacturing process scale-up and demonstration of formulation to make larger-quantity batches with improved microbial contamination control as compared to prior process.

2. Manufacture of two development batches (one slow-release, and the other fast-release).
a. Demo Batch 1: 1000 vials of slow-release.
b. Demo Batch 2: 1000 vials of fast-release.

3. Manufacture of two cGMP batches:
a. cGMP Batch 1: 1000 vials of slow-release.
b. cGMP Batch 2: 1000 vials of fast-release.

4. Release of each batch with certificates of analysis/testing.

5. OPTIONAL SERVICE: Stability study of each cGMP batch for up to 3 years.

Proposal Instructions

SOLICITATION QUESTIONS OR REQUESTS FOR CLARIFICATION DUE NO LATER THAN 1:00 PM (ET) FRIDAY, MARCH 8, 2024.
OFFEROR SUBISSIONS DUE NO LATER THAN 1:00 PM (ET) WEDNESDAY, APRIL 10, 2024.

Contact the POC, Ms. Heather Housaman at heather.housaman@nih.gov if interested in receiving the Full Solicitation Package.